Effect of tSCS on Ankle Movement Training in Individuals With SCI

NCT ID: NCT06596174

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2026-08-31

Brief Summary

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This clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tSCS), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (SCI). While epidural spinal cord stimulation (eSCS) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tSCS, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials.

The study aims to:

Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.

Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI.

The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.

Detailed Description

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Conditions

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SCI - Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stage 1: Healthy people

Identify optimal tSCS parameters for non-invasive spinal stimulation.

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulation (tSCS)

Intervention Type PROCEDURE

The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).

Stage 2: SCI Patients

Assess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.

Group Type EXPERIMENTAL

Short-term Machine-Assisted Ankle Movement Training with tSCS

Intervention Type PROCEDURE

The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time

Stage 3:SCI Patients

Long-term clinical effects of combined tSCS and ankle movement training

Group Type EXPERIMENTAL

Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS

Intervention Type PROCEDURE

The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS).

Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.

Stage 3:SCI Patients(Control)

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transcutaneous spinal cord stimulation (tSCS)

The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).

Intervention Type PROCEDURE

Short-term Machine-Assisted Ankle Movement Training with tSCS

The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time

Intervention Type PROCEDURE

Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS

The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS).

Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1\. Participants with chronic spinal cord injury, with injury duration greater than one year.

Exclusion Criteria

1. Musculoskeletal injuries on legs.
2. Osteoporosis.

SCI subjects:


1. Current musculoskeletal or joint injuries in the lower limbs.
2. History of central or peripheral neuromuscular diseases.
3. Presence of a pacemaker.
4. Current use of antispastic or antidepressant medications.
5. Current venous thromboembolism or osteoporosis.
6. Impairment of the soleus H-reflex arc.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

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Ya-Ju Chang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung University

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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Ya-Ju Chang, PhD

Role: primary

88632118800 ext. 5515

Other Identifiers

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SCI_001

Identifier Type: -

Identifier Source: org_study_id

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